Zugl.: Bern, Univ., Diss., 2007

The entire dissertation/thesis text is included in the research.pdf file; the official abstract appears in the short.pdf file (which also appears in the research.pdf); a non-technical general description, or public abstract, appears in the public.pdf file. Title from PDF of title page (University of Missouri--Columbia, viewed on April 1, 2010). Vita. Thesis advisor: Lawrence H. Ganong. "May 2008" Includes bibliographical references

Law / LL.M.

The subject of this thesis is one very important relationship of health care - the doctor- patient-relationship. During a recent decades a big attention was paid to this theme both on international and czech field. In the Czech Republic the doctor-patient-relationship went through the essential change, when instantly changed from a paternalistic relationship to a partnership. Many legal changes followed this change finishing it by accepting the Act on Healthcare Services which for example describes rights and duties of subjects of this relationship. The first part is dedicated to a doctor-patient-relationship itself. Its history and evolution, placement in a legal system, legal form. One part is dedicated to an ethic aspect of doctor-patient-relationship. The second part discusses about rights and duties of both participants of this relationship. Specifically, rights determined by the Act on Healthcare Services. The third part is dedicated to detailed analysis of some basic patient's rigths and the doctor's duties characterizing doctor-patient-relationship in its current form. These are informed consent, where I describe, why it is needed. I was concerned about its requisites, possibility to abandon informed consent, to informed dissent including its form while a short look on an issue of...

Collectivité d'outre-mer au sens des dispositions de l'article 74 de la Constitution de la Vème République, la Polynésie française est compétente en matière de santé. C'est à ce titre qu'elle élabore, en collaboration avec l'État, un droit médical spécifique, sensé répondre à ses particularités géographiques, démographiques et culturelles. De cette spécificité découle un droit médical s'éloignant peu à peu du droit métropolitain, entraînant une inégalité de droits et/ou devoirs entre patients/praticiens polynésiens et métropolitains, pourtant citoyens de la République française. C'est également au titre de sa compétence que la Polynésie française organise son système de santé. Organisé autour d'un secteur public hérité de l'époque coloniale, et d'un secteur libéral inspiré du modèle métropolitain, celui-ci atteint ses limites. Aussi des réformes, possiblement innovantes, sont nécessaires afin d'en assurer la pérennité. / French Polynesia is a French Oversea collectivity regarding the article 74 of the Constitution of the Vth Republic and is competent in health law and policies. It is as such that French Polynesia elaborates, in association with the French State, a specific medical law regarding its geographic, demographic and cultural specificities.From this organization ensues a local medical law marked by an increasing distortion with the metropolitan medical law, entailing an inequity of rights/duties between Polynesians and metropolitans patients/physicians, yet both being citizens of the French Republic.It is also on such basis that French Polynesia may organize its health service. Organized around a public sector inherited from colonial era, and a liberal sector inspired by the metropolitan model, the local health system reaches its limits. Hence, French Polynesia has to perform the necessary, and innovative, reforms to ensure the perpetuity of its health system.

Introduction and background Recruitment to cancer clinical trials needs to be improved, as does patient understanding about clinical trials, to enable patients to make an informed choice about whether or not to take part. The main reason that clinically eligible patients do not take part in clinical trials is because they refuse; poor understanding of the research has been associated with patient refusal. Audiovisual patient information (AVPI) has been shown to improve knowledge/understanding in various areas of practice but there is limited information about its effect in the cancer clinical trial setting, particularly in relation to recruitment rates. Understanding the research is necessary for informed consent, and it was hypothesised that if patient understanding about clinical trials was increased with AVPI, then this could result in a reduction in the number of patients refusing clinical trials, and therefore provide an ethical approach to improving recruitment. This study aimed to test the impact of an audiovisual patient information intervention on recruitment to randomised cancer clinical trials (refusal rates), patient understanding of the information given, and levels of anxiety. Reasons for patients’ decisions about trial participation were also assessed. Method An AVPI intervention was developed that aimed to address the common misconceptions associated with randomisation and clinical equipoise, as well as improve patient understanding generally of randomised cancer trials, and of other core clinical trial informational requirements, such as voluntariness. Patients were randomised to receive either AVPI in addition to the standard trial-specific written information, or the written information alone. A new questionnaire was developed to assess patient understanding (also referred to as knowledge) in the randomised trial setting and, following testing with patients and research nurses, this was shown to be reliable and valid. Patients completed self-report questionnaires to assess their understanding (new knowledge questionnaire) and anxiety (Spielberger State-Trait Anxiety Inventory), at baseline and after they had made their decision about clinical trial entry, when their perceptions of the intervention, as well as factors contributing to their decision were also determined (this tool incorporated Jenkins and Fallowfield’s (2005) questionnaire which assessed reasons for accepting and declining randomised cancer trials). Results A total of 173 patients with breast cancer (65%), colorectal cancer (32%) and lung cancer (3%) were entered into the main study. The median age was 60 (range 37-92 years). There was no difference in clinical trial recruitment rates between the two groups: 72.1% in the AVPI group and 75.9% in the standard information group. The estimated odds ratio for refusal (intervention/no intervention) was 1.19 (95% ci 0.55-2.58, p=0.661). Knowledge scores increased more in the intervention group compared to the standard group (U= 2029, p=0.0072). The change in anxiety score between the arms was also statistically significant (p=0.011) with anxiety improving in the intervention arm more than in the no-intervention arm. The estimated difference in the median anxiety change score between the groups is –4.6 (95% ci –7.0 to –2.0). Clinical trial entry was not influenced by tumour type, stage of cancer, age, educational qualifications or previous research experience, however, there was a modest association with deprivation status (p=0.046) where more affluent patients were the least likely to consent to a trial. Educational qualifications and stage of cancer were independently associated with knowledge: patients who were better educated had higher levels of knowledge about randomised trials, and patients who had limited stage of cancer had higher baseline knowledge than patients with advanced cancer. Acceptability of the intervention was high with 93% of those who watched it finding it useful, and 42% stating that it made them want to take part in the clinical trial. Personal benefit and altruism were key motivating factors for clinical trial participation, with reasons for refusal being less clear. Discussion and conclusions Although the potential for AVPI to increase clinical trial recruitment rates was highlighted in the literature, in this study, AVPI was not shown to have any effect on refusal rates to randomised cancer trials. However, by improving patient understanding prior to decision making, AVPI was shown to be a useful addition to the consent process for randomised cancer trials. AVPI addresses the fundamental ethical challenges of informed consent by improving patient understanding, and supports the ethical framework integral to Faden and Beauchamp’s (1986) theory of informed consent. The new knowledge questionnaire was shown to be a sensitive and effective instrument for measuring understanding of randomised clinical trials in the cancer setting, although it would benefit from further testing. The AVPI appears to reduce anxiety at the decision making time point and has been shown to be an acceptable medium for patients. This study confirms existing findings from studies assessing factors affecting decision making, with personal benefit and altruism being key motivating factors, and reasons for refusal being less clear. The need for further qualitative work in this area is highlighted to gain a deeper understanding of what is important to patients, in terms of why they refuse clinical trial participation. Implications for practice and further research Several implications for practice have been identified, including using AVPI as part of the standard information package for patients considering randomised cancer trials, and focussing on patient and staff education in this area. The knowledge questionnaire could be introduced to routine practice as a tool to determine patient understanding prior to decision making, allowing clinicians the opportunity to correct any misconceptions prior to consent. Further research focussing on AVPI specific to individual trials would be helpful, to determine if a more customised approach would be of benefit in terms of clinical trial recruitment. The importance of studying other aspects of the consent process such as the interaction between the clinician and the patient, in addition to more detailed exploration of the factors affecting patients’ decisions were highlighted.

Diploma thesis "Development of Czech medical law in the context of health-related human rights" deals with Czech medical law and its development after the year 1989 in connection with the human rights. Also this thesis deals with the area of human rights with their relation to health, especially in the time of the current health reforms. The aim of the thesis is, based on the analysis of the current findings, to find out the deficits of the protection of human rights regarding the modernization of health law and to identify the reasons of the failure of the implementation of the norms and laws concerning the human rights and their connection to health in the Czech legal system.

5 Hana Tošnarová The topics of ethicin professional nurse behaviour in the care of psychiatric patients Abstract Presented dissertation theses are dedicated to the ethic aspects of the professional behaviour of nurses in their care of the mental patients. In the theroretical part are described thesis connected with the profession of psychiatric nurses, with the psychiatry as a medial branch, legislation in the psychiatry and with the questions of ethics in the connection of nursing. The practical part, that describes the qualitative research, is divided into two subsections and observing. The phenomenal study went through in the Mental home of Bohnice (Prague) and the output was the determination of defined notion "professional behaviour of a nurse in the care of mental patients in the scope of ethics". The second part of the observation was targeted on the access of the nurses to the mental patients in the special handpicked working places of the somatic medicine in Prague. The output of this research is a description of the behaviour style of nurses in the somatic working places in an interaction with mental patients. Keywords: ethics in nursery, ethics in psychiatry, ethics in medicíně, professional behaviour of a nurse, nursing, medical law

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5 Hana Tošnarová The topics of ethicin professional nurse behaviour in the care of psychiatric patients Abstract Presented dissertation theses are dedicated to the ethic aspects of the professional behaviour of nurses in their care of the mental patients. In the theroretical part are described thesis connected with the profession of psychiatric nurses, with the psychiatry as a medial branch, legislation in the psychiatry and with the questions of ethics in the connection of nursing. The practical part, that describes the qualitative research, is divided into two subsections and observing. The phenomenal study went through in the Mental home of Bohnice (Prague) and the output was the determination of defined notion "professional behaviour of a nurse in the care of mental patients in the scope of ethics". The second part of the observation was targeted on the access of the nurses to the mental patients in the special handpicked working places of the somatic medicine in Prague. The output of this research is a description of the behaviour style of nurses in the somatic working places in an interaction with mental patients. Keywords: ethics in nursery, ethics in psychiatry, ethics in medicíně, professional behaviour of a nurse, nursing, medical law